W
Dont want to start a new topic with this one already open for discussion. My question is (somewhat) related so i figured this is as good a place as any...
Our company is certified to 9001:2003 & 13485:2008 but we have never done manufacture of a medical device.
We are now currently in the early stages of a possible FDA regulated medical device project. With this in mind and the pending changes to our 13485 registration to meet the new standard, we are looking at various ways to meet the requirements of validation for both product and software contributing to processes or product.
One option that management has presented is to return to paper copies of certain documentation to meet the signature needs. I'm reluctant to take a step backwards and am sure there must be some affordable solutions on the market.
Does anyone have any suggestions of or experience with certificate authority providers, electronic signature software, or other validation methods to meet the FDA requirements (part 11) and similar regulatory requirements for 13485?
Any help or recommendation would be greatly appreciated.
thanks!
w.
Our company is certified to 9001:2003 & 13485:2008 but we have never done manufacture of a medical device.
We are now currently in the early stages of a possible FDA regulated medical device project. With this in mind and the pending changes to our 13485 registration to meet the new standard, we are looking at various ways to meet the requirements of validation for both product and software contributing to processes or product.
One option that management has presented is to return to paper copies of certain documentation to meet the signature needs. I'm reluctant to take a step backwards and am sure there must be some affordable solutions on the market.
Does anyone have any suggestions of or experience with certificate authority providers, electronic signature software, or other validation methods to meet the FDA requirements (part 11) and similar regulatory requirements for 13485?
Any help or recommendation would be greatly appreciated.
thanks!
w.

